The Intention-to-treat Effect of Bridge Therapies in the Setting of Milan-in Patients

NCT03723304 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1083

Last updated 2018-10-29

No results posted yet for this study

Summary

In patients with hepatocellular cancer (HCC) meeting the Milan Criteria (MC), the usefulness of loco-regional therapies (LRT) in the context of liver transplantation (LT) is still debated. The inconsistent literature data are the result of initial selection biases among treated and untreated patients. In order to overcome these shortcomings, an inverse probability of treatment weighting (IPTW) analysis was done in a large patient cohort. After using a competing-risk analysis, the primary end-point of the study aims at identifying the risk factors of HCC-specific LT failure, defined as pre-LT tumour-related drop-out or post-LT recurrence.

Conditions

Interventions

PROCEDURE

Bridging followed by transplant

Trans-arterial chemoembolization or percutaneous alcohol injection or radio-frequency ablation during the waiting time followed by liver transplant

PROCEDURE

Direct liver transplant

Direct liver transplant (no neoadjuvant approaches during the waiting time period)

Sponsors & Collaborators

  • European Hepatocellular Cancer Liver Transplant Group

    lead OTHER

Principal Investigators

  • Quirino Lai, MD PhD · UCL Brussels

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-10-15
Completion
2018-10-15

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03723304 on ClinicalTrials.gov